BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 1131919 · Received August 22, 2008

    Report

    Report Number
    1213643-2008-00409
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    November 15, 2006
    Report Date
    July 28, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K021736
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AS NO PROD HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE WILL SUBMIT A F/U REPORT WHEN/IF PROD IS RETURNED FOR EVAL OR ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: IN 2006--THE PT WAS REPORTED TO HAVE BEEN FOUND TO HAVE AN INCARCERATED VENTRAL HERNIA. AT ABOUT TWO WEEKS LATER, THE PT UNDERWENT EMERGENCY HERNIA REPAIR SURGERY WITH PLACEMENT OF A VENTRALEX PATCH. AT APPROX 6 DAYS LATER, THE PT WAS ADMITTED TO THE EMERGENCY DEPT WITH REPORTS OF PAIN AND SIGNS OF INFECTION. AT ABOUT 15 DAYS LATER, THE PT UNDERWENT SURGERY WITH REMOVAL OF THE OLD MESH, REPAIR OF AN ENTEROVESICAL FISTULA, REPAIR OF A PERFORATION TO THE SIGMOID COLON, RESECTION OF THE COLON AND TO MAKE A COLOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - VENTRALEX FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43CQD590

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R